Isis Pharmaceuticals Inc. said it will discontinue development of its experimental rheumatoid arthritis drug following poor Phase 2 trial results.
It said patients taking the antisense drug ISIS-CRPRx for alleviating symptoms of rheumatoid arthritis showed statistically insignificant results.
Though patients in the trial did show improvement, it was not significant when compared with those in the placebo group, the company added.
As of now, the company doesn’t plan to further develop the C-reactive protein for rheumatoid arthritis. However, it will continue to evaluate the same as a treatment option for other diseases.
The halted trail
For the Phase II trail researchers had enrolled 51 rheumatoid arthritis patients. All patients had chronically elevated levels of C-reactive protein (CRP) which is strongly linked with several inflammatory and cardiovascular ailments.
The patients were either required to take 100 mg, 200 mg, or a 400 mg dose of ISIS-CRP or a placebo for 12 weeks.
While the patients in the active group did report a 67 percent drop in the CRP levels, the overall improvement in rheumatoid arthritis symptoms were not statistically significant in comparison to the placebo group, researchers said.
“We are pleased with the consistency of CRP lowering across all of our clinical studies, but we are disappointed that we did not see a greater impact on RA [rheumatoid arthritis] symptoms in these patients,” the company statement quoting Richard Geary, an Isis senior vice president of development, stated.
The patients who were treated with the Isis drug “achieved substantial, dose-dependent reductions in CRP early in treatment [and] that were prolonged through the treatment process as well as improvements in the symptoms of rheumatoid arthritis. The improvements correlated with reductions in CRP, but were not sufficiently greater than improvements observed in the placebo groups to justify further development of the drug for rheumatoid arthritis, the company statement read.